Category: Europe

July 22, 2019 Off

FDA grants first approvals for generics of Lyrica

By Dino Mustafić

The FDA has granted first approvals for the generic versions of Lyrica to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals.

July 22, 2019 Off

Bayer recalls two lots of Kogenate

By Dino Mustafić

Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level, the company said Monday in a statement.

July 18, 2019 Off

Three companies to evaluate the combination of Bayer’s kinase inhibitor Stivarga and BMS’s Opdivo

By BusinessWire

Bayer, Bristol-Myers Squibb Company (NYSE: BMY) and Ono Pharmaceutical Co., Ltd. (“Ono”) announced today the three companies have entered into a clinical collaboration agreement to evaluate the combination of Bayer’s kinase inhibitor Stivarga® (regorafenib) and Bristol-Myers Squibb’s / Ono’s anti-PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab) in patients with micro-satellite stable metastatic colorectal cancer (MSS mCRC), the most common form of mCRC.1